1.0 Purpose: To lay down a procedure for Locations, limits, and frequency of nonviable particle count.2.0 Aim: This SOP is applicable to nonviable particle count locations, limits, and their frequency in the Production facility.3.0 Responsibility:3.1 Sr. Officer / Officer & line coordinator shall execute this SOP.3.2 In-charge / Head shall supervise that the process is … Read more
1.0 Purpose: To lay down the procedure for packing vials.2.0 Aim: This Standard Operating Procedure is applicable for packing vaccine vials in the Packing Section.3.0 Responsibility: 3.1 Trained operators and casual workers shall be responsible for packing activity.3.2 Officer/ Senior officer of Production shall be responsible for checking the activity.3.3 IPQA person shall be responsible … Read more
Goa is a state in western India with a coastline that goes all the way to the Arabian Sea. There is a presence of Small, Medium, and Large-Scale Pharmaceutical Companies. The majority of pharmaceutical companies are part of multinational corporations, as well as the Indian private and public sectors. Pharmaceutical companies in Goa deliver a … Read more
The audit is an important aspect of determining the growth and market existence of any organization, particularly in the pharmaceutical sector. The success rate of an audit relies on multiple factors, some of the Audit Check List for Quality Assurance are described below: 1.0 Quality Assurance Department 1.1 Does the company have a later quality … Read more
1.0 Purpose: To lay down the procedure for Receiving and Transfer the FGTN to Warehouse.2.0 Aim This Standard Operating Procedure is applicable to the packing Department in Pharmaceutical.3.0 Responsibility: 3.1 Trained operators/ line coordinators shall be responsible for receiving and transferring the material.3.2 Officer/Executives of production shall be responsible for checking the activity.3.3 IPQA in … Read more
The audit is an important aspect of determining the growth and market existence of any organization, particularly in the pharmaceutical sector. the success of an audit relies on multiple factors, some of the audit Audit Checklist for Quality Control are described below: 1.0 Audit Checklist Quality Control Department 1.1 Does the QC lab have SOPs … Read more
1.0 Purpose: To lay down the standard operating procedure for cleaning and operation of carton coding machine.2.0 Aim: This SOP is applicable to the carton coding machines installed in the Production. 3.0 Responsibility:3.1 Line operator shall be responsible for cleaning and operation of carton coding machine3.2 Officer / Sr. Officer shall be responsible for supervising … Read more
1.0 Purpose: To describe the procedure for decontamination of used material that comes in contact with API.2.0 Aim: This Standard Operating Procedure is applicable for the decontamination of used material in the production department. 3.0 Responsibility: 3.1 Trained line coordinators shall carry out the decontamination process of used materials.3.2 Officers/Sr. Officers shall be responsible to … Read more
An audit is a main element in determining the growth and market presence of any organization. The success of an audit is dependent on various factors, that need to be reduced. some of the Audit Checklist for Human Resources and Administration that can be used are described below: 1.0 Personnel Audit Checklist A. Key Personnel … Read more
Due to the growing demand for GMP and regulatory requirements in the pharmaceutical industry, there is a high chance of deviations occurring. These deviations must be documented, and the manufacturing organization recognizes the need for a standard operating procedure (SOP) for handling such deviations. However, even with good compliance practices in place, there may still … Read more
FBD refers to a Fluidized bed dryer that is commonly used in the pharmaceutical industry to reduce the moisture content of pharmaceutical granules. It is the best technique used by the manufacturer to produce a good quality product. However, with time, new advanced techniques are introduced to replace old like; in case of FBD, a … Read more
1.0 Objective: To lay down the procedure for handling filled bottles labeled with improper labels.|2.0 Scope:This procedure is applicable for filled bottles with improper labels in the liquid packing department in Pharmaceuticals3.0 Responsibility:Officer – Production department to implement this standard operating procedure.Manager- Production Department to overall compliance to this operating procedure 4.0 Procedure: 4.1 Types … Read more
Change control is Managing to control a change in a process/procedure/system through proper and scientific justification, review, approval, implementation, follow-up, and closure. EU GMP Annex 15 Guidelines explain “change control” as: “The given statement describes a formal process in which qualified individuals from relevant fields review proposed or actual changes that could potentially affect the … Read more
1.0 Objective: To lay down a procedure for cleaning and operation of inspection unit for empty and filled bottles.2.0 Scope: This Standard operating procedure is applicable for cleaning and operation of the inspection unit for empty and filled bottles in the Liquid department. 3.0 ResponsibilityOperator, officer – Production departmentManager-QA, Production department 4.0 Procedure 4.1 Cleaning4.1.1 … Read more
Track and trace system in pharmaceuticals is a process of determining the current and past history of products through their unique ID, or their properties. It helps the manufacturer to get information about false or copied products in the market. Track system is simply to know about the current and past location of any serialized … Read more
1.0 Objective: To lay down a procedure for Cleaning utensils, SS accessories, and machine change parts.2.0 Scope: This procedure is applicable to cleaning utensils, SS accessories, and machine change parts in the Liquid orals department.3.0 Responsibility: Operator, Officer, Executive – Production DepartmentManager – Production Department 4.0 Procedure: 4.1 Cleaning Procedure of SS Accessories after every … Read more